# Pentax of America, Inc.

- Location (FDA's records): Montvale, NJ
- FDA decisions: 44 (2012–2025): 44 510(k) clearances
- Product codes: EOQ (9), ODG (6), PEA (6), FDS (5), FDT (5), EOB (4), GEH (3), FDF (2), PCV (1), ODC (1), EOX (1), FET (1)
- 510(k) review time since 2016: median 163 days, against 134 for FDA's reviews in the same codes and years (8 of 27 faster)
- Predicates its devices cite: 60 (23 its own); citations of its devices by later devices: 30 (23 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pentax Medical Company: 29 (https://510kreport.com/company/pentax-medical)
- Olympus Medical Systems Corp.: 3 (https://510kreport.com/company/olympus-medical-systems)
- Ambu A/S: 1 (https://510kreport.com/company/ambu-a-s)
- Byrne Medical, Inc.: 1 (https://510kreport.com/company/byrne-medical)
- Pentax Medical, A Division of Pentax of America, Inc.: 1 (https://510kreport.com/company/pentax-medical-a-division-of-pentax-of-america)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Fujinon, Inc.: 1 (https://510kreport.com/company/fujinon)

## Firms that cite its devices most
- Pentax Medical Company: 3 (https://510kreport.com/company/pentax-medical)
- Endosound, Inc.: 1 (https://510kreport.com/company/endosound)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Sonoscape Medical Corp.: 1 (https://510kreport.com/company/sonoscape-medical)
- Smart Medical Systems, Ltd.: 1 (https://510kreport.com/company/smart-medical-systems)

## Its most-cited devices
- K192245: Pentax Medical Video Duodenoscope ED34-i10T2 (2019), cited by 3
- K162151: PENTAX Medical ENT Video Imaging System (2017), cited by 3
- K150618: PENTAX Medical EPK-i7010 Video Processor with GI Family (2015), cited by 2
- K200090: PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) (2020), cited by 2
- K181522: PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope (2018), cited by 2
- K182846: PENTAX Medical EPK-3000 Video Imaging System (2019), cited by 1

## Recent decisions
- K251256: PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) (Dec 16, 2025)
- K251127: PENTAX Medical Video Processor (EPK-i8020c) (Jun 3, 2025)
- K242110: PENTAX Medical Video Colonoscope (EC38-i20cWL) (Jan 3, 2025)
- K241213: PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) (Dec 6, 2024)
- K233942: PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) (Aug 1, 2024)
- K240457: C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (Jul 24, 2024)
- K232860: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (Jan 18, 2024)
- K231970: PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock (Jan 12, 2024)

Source page: https://510kreport.com/company/pentax-of-america